BEUDAMED
    FDA Recall Terminated

    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

    Recall: Z-2058-2014 · Initiated June 9, 2014

    Recall

    Recall Number
    Z-2058-2014
    Event Number
    68595
    Firm
    Siemens Healthcare Diagnostics Inc.
    FEI Number
    3005250747
    Product Code
    CIZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 9, 2014
    Posted
    July 15, 2014
    Terminated
    July 24, 2015
    Address
    5736 W 96th St, Los Angeles, CA, 90045-5544

    Description

    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics

    Reason

    The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.

    Action

    A recall letter dated 6/9/14 was sent to all customers who purchased the Coat-A-Count Direct Androstenedione because the assay is demonstrating a higher frequency of results compared to alternate platforms. The letter informs the customers of the problems identified, risks to health, and actions to be taken. Customers are instructed to complete and return the Field Correction Effectiveness Check attached to the recall letter within 30 days.

    Distribution

    Worldwide Distribution. US nationwide including CA, MI, NC, NE, NY, OH, PA, TX, and VA; Argentina, Austria, Belgium, Bolivia, Canada, Chile, Colombia, Finland, Germany, Great Britain, Greece, India, Ireland, Italy, Japan, Korea, Netherlands, Paraguay, Peru, South Africa, Spain, Sweden, Switzerland, and Uruguay

    Quantity

    1,164 units